Jean-François Kleinmann1, Florence Tubach2, Véronique Le Guern3, Alexis Mathian4, Christophe Richez5, David Saadoun6, Karim Sacre7, Jérémie Sellam8, Raphaèle Seror9, Zahir Amoura4, Emmanuel Andres10, Sylvain Audia11, Brigitte Bader-Meunier12, Gilles Blaison13, Bernard Bonnotte11, Patrice Cacoub14, Sophie Caillard15, Laurent Chiche16, Olivier Chosidow17, Nathalie Costedoat-Chalumeau18, Claire Daien19, Eric Daugas20, Nairouz Derdèche1, Andrea Doria21, Olivier Fain22, Fadi Fakhouri23, Dominique Farge24, Cem Gabay25, Sylvie Guillo26, Eric Hachulla27, Najia Hajjaj-Hassouni28, Mohamed Hamidou29, Frédéric A Houssiau30, Noémie Jourde-Chiche31, Isabelle Koné-Paut32, Aïcha Ladjouz-Rezig33, Olivier Lambotte34, Dan Lipsker35, Xavier Mariette9, Nicolas Martin-Silva36, Thierry Martin37, François Maurier38, Roderich Meckenstock39, Arsène Mékinian40, Olivier Meyer41, Shirine Mohamed42, Jacques Morel19, Bruno Moulin43, Denis Mulleman44, Thomas Papo45, Vincent Poindron46, Xavier Puéchal47, Leonardo Punzi21, Pierre Quartier12, Laurent Sailler48, Amar Smail49, Martin Soubrier50, Agnès Sparsa50, Zoubida Tazi-Mezalek51, Leith Zakraoui52, Stéphane Zuily53, Jean Sibilia54, Jacques-Eric Gottenberg55. 1. Rheumatology Department, Strasbourg University Hospital, Strasbourg, France. 2. Epidemiology and Clinical Research, AP-HP, Pitié-Salpétrière Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France. 3. Internal Medicine Department, AP-HP, Cochin Hospital, Paris, France; Université René-Descartes Paris V, Paris, France. 4. Internal Medicine Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France. 5. Rheumatology Department, Bordeaux University Hospital, University of Bordeaux, Bordeaux, France. 6. Internal Medicine and Clinical Immunology Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France. 7. Internal Medicine Department, AP-HP, Bichat Hospital, INSERM U1149, Paris, France; Université René-Descartes Paris V, Paris, France. 8. Rheumatology Department, AP-HP, Saint Antoine Hospital, INSERM UMRS_938, DHU i2B, Paris, France; Université Pierre et Marie Curie, Paris 6, France. 9. Rheumatology Department, AP-HP, Bicêtre Hospital, Le Kremlin Bicêtre, France; Université Paris Sud, Le Kremlin Bicêtre, France. 10. Internal Medicine Department, Strasbourg University Hospital, Strasbourg, France; Université de Strasbourg, Strasbourg, France. 11. Internal Medicine and Clinical Immunology Department, Dijon University Hospital, University of Bourgogne Franche-Comté, INSERM UMR 1098, FHU INCREASE, Dijon, France. 12. Paediatric Immunology and Rheumatology Department, AP-HP, Necker Hospital, Institut Imagine, Paris, France. 13. Internal Medicine Department, Colmar Hospital, Colmar, France. 14. Internal Medicine and Clinical Immunology Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France. 15. Nephrology Department, Strasbourg University Hospital, Strasbourg, France. 16. Internal Medicine Department, Hôpital Européen, Marseille, France. 17. Dermatology Department, AP-HP, Henri Mondor Hospital, Paris, France. 18. Internal Medicine Department, AP-HP, Cochin Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France. 19. Rheumatology Department, Montpellier University Hospital, Montpellier, France. 20. Nephrology Department, AP-HP, Bichat Hospital, Paris, France. 21. Medicine Department-DIMED, University of Padova, Padova, Italy. 22. Internal Medicine Department, AP-HP, Saint Antoine Hospital, Paris, France; Université Pierre et Marie Curie, Paris 6, France. 23. Nephrology Department, Nantes University Hospital, Nantes, France. 24. Internal Medicine Department, AP-HP, Saint Louis Hospital, University of Paris Diderot, Paris, France. 25. Rheumatology Department, Geneva University Hospital, Geneva, Switzerland. 26. Epidemiology and Clinical Research, AP-HP, Pitié-Salpétrière Hospital, Paris, France. 27. Internal Medicine Department, Lille University Hospital, University of Lille, Lille, France. 28. Rheumatology Department, El Ayachi University Hospital, URAC 30, Faculty of Medicine, Salé, Morocco; University Mohammed V, Rabat, Morocco. 29. Internal Medicine Department, Nantes University Hospital, Nantes, France. 30. Pôle de maladies rhumatismales, Université Catholique de Louvain, Louvain-la-Neuve, Belgium. 31. Nephrology Department, AP-HM, Marseille University Hospital, University Aix-Marseille, Marseille, France. 32. Paediatric Rheumatology Department, AP-HP, Bicêtre Hospital, Le Kremlin Bicêtre, France; Université Paris Sud, Le Kremlin Bicêtre, France. 33. Medicine Department, University of Algiers 1, Algiers, Algeria. 34. Internal Medicine and Clinical Immunology Department, AP-HP, Bicêtre Hospital, Le Kremlin Bicêtre, France; INSERM UMR 1184, Immunologie des Maladies Virales et Autoimmunes (IMVA), Le Kremlin Bicêtre, France; CEA, DSV/iMETI, Division of Immuno-Virology, IDMIT, France; Université Paris Sud, Le Kremlin Bicêtre, France. 35. Dermatology Department, Strasbourg University Hospital, Strasbourg, France; Université de Strasbourg, Strasbourg, France. 36. Internal Medicine Department, Caen University Hospital, Caen, France. 37. Internal Medicine and Clinical Immunology Department, Strasbourg University Hospital, Strasbourg, France; IBMC, CNRS, UPR3572, Strasbourg, France; Université de Strasbourg, Strasbourg, France. 38. Internal Medicine Department, Metz Hospital, Metz, France. 39. Internal Medicine and Infectious Diseases Department, Versailles Hospital, Versailles, France. 40. Internal Medicine Department, AP-HP, Saint Antoine Hospital, Paris, France. 41. Rheumatology Department, AP-HP, Bichat Hospital, Paris, France. 42. Internal Medicine Department, Nancy University Hospital, Nancy, France; Université de Lorraine, Nancy, France. 43. Nephrology Department, Strasbourg University Hospital, Strasbourg, France; Université de Strasbourg, Strasbourg, France. 44. Rheumatology Department, Tours University Hospital, University François Rabelais, CNRS 7292, Tours, France. 45. Internal Medicine Department, AP-HP, Bichat Hospital, INSERM U1149, Paris, France. 46. Internal Medicine and Clinical Immunology Department, Strasbourg University Hospital, Strasbourg, France. 47. Internal Medicine Department, AP-HP, Cochin Hospital, Paris, France. 48. Internal Medicine Department, Toulouse University Hospital, Toulouse, France. 49. Internal Medicine Department, Amiens University Hospital, Amiens, France. 50. Dermatology Department, Clinique Mutualiste Catalane, Perpignan, France. 51. Internal Medicine Department, Ibn Sina Hospital, Rabat, Morocco; University Mohammed V, Rabat, Morocco. 52. Rheumatology Department, Tunis University Hospital, Tunis, Tunisia. 53. Vascular Medicine Department, Nancy University Hospital, INSERM U1116, Nancy, France; Université de Lorraine, Nancy, France. 54. Rheumatology Department, Strasbourg University Hospital, Strasbourg, France; INSERM UMR_S1109, Fédération de Médecine Translationnelle de Strasbourg (FMTS), FHU OMICARE, Strasbourg, France; Université de Strasbourg, Strasbourg, France. 55. Rheumatology Department, Strasbourg University Hospital, Strasbourg, France; IBMC, CNRS, UPR3572, Strasbourg, France; Université de Strasbourg, Strasbourg, France. Electronic address: jacques-eric.gottenberg@chru-strasbourg.fr.
Abstract
BACKGROUND/ PURPOSE: Despite conventional immunosuppressants, active and steroid-dependent systemic lupus erythematosus (SLE) represents a therapeutic challenge. Only one biologic, belimumab, has been approved, but other biologics are sometimes used off-label. Given the lack of evidence-based data in some clinical situations encountered in real life, we developed expert recommendations for the use of biologics for SLE. METHODS: The recommendations were developed by a formal consensus method. This method aims to formalize the degree of agreement among experts by identifying, through iterative ratings with feedback, the points on which experts agree, disagree or are undecided. Hence, the recommendations are based on the agreed-upon points. We gathered the opinion of 59 French-speaking SLE experts from 3 clinical networks dedicated to systemic autoimmune diseases (FLEUR, IMIDIATE, FAI2R) from Algeria, Belgium, France, Italy, Morocco, Switzerland and Tunisia. Represented medical specialities were internal medicine (49%), rheumatology (34%), nephrology (7%), dermatology (5%), pediatrics (3%) and cardiology (2%). Two methodologists and 3 strictly independent SLE expert groups contributed to developing these recommendations: a steering group (SG) (n=9), an evaluation group (EG) (n=28) and a reading group (RG) (n=22). Preliminary recommendations were drafted by the SG, then proposed to the EG. Each EG member rated the degree of agreement from 1 to 9 (1: lowest; 9: strongest) for each recommendation. After 2 rating rounds, the SG submitted a new version of the recommendations to the RG. With comments from the RG, the SG finalised the recommendations. RESULTS: A total of 17 final recommendations were formulated by the SG, considering all agreement scores and comments by the EG and RG members and the two methodologists. These recommendations define the subset of patients who require a biologic; the type of biologics to use (belimumab, rituximab, etc.) depending on the organ involvement and associated co-treatments; what information should be given to patients; and how to evaluate treatment efficacy and when to consider discontinuation. CONCLUSION: Overall, 17 recommendations for the good use of biologics in SLE were formulated by a large panel of SLE experts to provide guidance for clinicians in daily practice. These recommendations will be regularly updated according to the results of new randomized trials and increasing real life experience.
BACKGROUND/ PURPOSE: Despite conventional immunosuppressants, active and steroid-dependent systemic lupus erythematosus (SLE) represents a therapeutic challenge. Only one biologic, belimumab, has been approved, but other biologics are sometimes used off-label. Given the lack of evidence-based data in some clinical situations encountered in real life, we developed expert recommendations for the use of biologics for SLE. METHODS: The recommendations were developed by a formal consensus method. This method aims to formalize the degree of agreement among experts by identifying, through iterative ratings with feedback, the points on which experts agree, disagree or are undecided. Hence, the recommendations are based on the agreed-upon points. We gathered the opinion of 59 French-speaking SLE experts from 3 clinical networks dedicated to systemic autoimmune diseases (FLEUR, IMIDIATE, FAI2R) from Algeria, Belgium, France, Italy, Morocco, Switzerland and Tunisia. Represented medical specialities were internal medicine (49%), rheumatology (34%), nephrology (7%), dermatology (5%), pediatrics (3%) and cardiology (2%). Two methodologists and 3 strictly independent SLE expert groups contributed to developing these recommendations: a steering group (SG) (n=9), an evaluation group (EG) (n=28) and a reading group (RG) (n=22). Preliminary recommendations were drafted by the SG, then proposed to the EG. Each EG member rated the degree of agreement from 1 to 9 (1: lowest; 9: strongest) for each recommendation. After 2 rating rounds, the SG submitted a new version of the recommendations to the RG. With comments from the RG, the SG finalised the recommendations. RESULTS: A total of 17 final recommendations were formulated by the SG, considering all agreement scores and comments by the EG and RG members and the two methodologists. These recommendations define the subset of patients who require a biologic; the type of biologics to use (belimumab, rituximab, etc.) depending on the organ involvement and associated co-treatments; what information should be given to patients; and how to evaluate treatment efficacy and when to consider discontinuation. CONCLUSION: Overall, 17 recommendations for the good use of biologics in SLE were formulated by a large panel of SLE experts to provide guidance for clinicians in daily practice. These recommendations will be regularly updated according to the results of new randomized trials and increasing real life experience.
Authors: May Y Choi; Kelsey Flood; Sasha Bernatsky; Rosalind Ramsey-Goldman; Ann E Clarke Journal: Best Pract Res Clin Rheumatol Date: 2017-11-10 Impact factor: 4.098
Authors: Pedro Mendes-Bastos; Ana Brasileiro; Pavel Kolkhir; Stefan Frischbutter; Jörg Scheffel; Sherezade Moñino-Romero; Marcus Maurer Journal: Allergy Date: 2022-02-28 Impact factor: 14.710